NCT07083011

Brief Summary

The purpose of this study is to assess the performance of 68Ga- FAPI PET in heart failure with preserved ejection fraction (HFpEF)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
13mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Nov 2025Jul 2027

First Submitted

Initial submission to the registry

July 16, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

July 16, 2025

Last Update Submit

April 22, 2026

Conditions

Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (4)

  • Myocardial 68Ga-FAPI (68Ga-Fibroblast Activation Protein Inhibitor) volume

    Myocardial 68Ga-FAPI volume will be determined by a PET (positron emission tomography) scan and measured in cm3

    Baseline and 6 Months

  • Mean Standardized Uptake Value (SUVmean) and Max Standardized Uptake Value (SUVmax)

    SUVmean and SUVmax will be determined by a PET (positron emission tomography) scan and measured as a dimensionless ratio

    Baseline and 6 Months

  • Area of 68Ga-FAPI (68Ga-Fibroblast Activation Protein Inhibitor) uptake

    Area of 68Ga-FAPI will be determined by a PET (positron emission tomography) scan and measured as a % of polar map.

    Baseline and 6 Months

  • 68Ga-FAPI target-to-background ratio

    68Ga-FAPI target-to-background ratio will be determined by a PET (positron emission tomography) scan and measured as a dimensionless ratio.

    Baseline and 6 Months

Study Arms (3)

Obese subjects with HFpEF (heart failure with preserved ejection fraction)

EXPERIMENTAL
Drug: 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor)

Active cardiac sarcoidosis

ACTIVE COMPARATOR
Drug: 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor)

Healthy subjects

ACTIVE COMPARATOR
Drug: 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor)

Interventions

68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor)DRUG

68Ga-FAPI is a gallium-68 fibroblast activation protein inhibitor that will be injected into subjects during a PET (positron emission tomography) scan

Active cardiac sarcoidosisHealthy subjectsObese subjects with HFpEF (heart failure with preserved ejection fraction)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged ≥ 30 years old with exertional dyspnea (NYHA II and III) and LVEF ≥50%
  • BMI ≥ 30
  • New diagnosis of HFpEF based on RHC at baseline (elevated PCWP at rest and/or during exercise)

You may not qualify if:

  • Primary cardiomyopathy or pericardial disease or ≥ moderate valvular disease
  • Dyspnea due to lung disease or CAD
  • Severe anemia, liver, or renal disease
  • Active cancer
  • Systemic active inflammatory or autoimmune disease (e.g. rheumatoid arthritis, SLE, etc.)
  • Recent hospitalization (\< 30 days) or coronary revascularization (\< 90 days)
  • Patients already taking SGLT2i and/or GLP-1A
  • Pregnant or breastfeeding
  • Inability to tolerate supine position for the PET/CT or CMR scans.
  • Contraindications for safe CMR scanning (e.g., uncontrolled claustrophobia, cochlear implant, implanted neural stimulator)
  • Known gadolinium allergy
  • Presence of implantable cardiac pacemaker or defibrillator or mechanical valve.
  • Ambulatory patients aged ≥ 18 years old
  • New referrals to the Sarcoid Clinic with a confirmed but untreated diagnosis of definite or probable CS based on 2014 HRS consensus (see Table 2)
  • With a positive cardiac 18F-FDG PET scan within 30 days.
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Interventions

68Ga-FAPI

Study Officials

  • Omar Abou Ezzeddine, M.D, M.S

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Gregorio Tersalvi, M.D

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jake Nemgar

CONTACT

507-266-8774nemgar.jacob@mayo.edu

Gregorio Tersalvi, M.D

CONTACT

tersalvi.gregorio@mayo.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 16, 2025

First Posted

July 24, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)